The goal of this observational study is to learn if offering a point-of-care screening test for exposure to the Hepatitis C virus, before providing a diagnostic test for Hepatitis C infection can increase testing, diagnosis and treatment in Adults. Participants will be recruited from settings that provide services to people with a risk factor for the acquisition of Hepatitis C viral infection. The main question it aims to answer is: What proportion of the participants that have been diagnosed with HCV infection have started treatment when their records are reviewed 12 weeks after diagnosis? Participants will have one in-person visit where they will provide informed consent and receive a finger-prick rapid result test for Hepatitis C infection. Participants with no previous Hepatitis C infection will have a screening test to see if they have an immune reaction to Hepatitis C. Participants who know they have been infected with Hepatitis C in the past, and all participants with a positive screening test result will then be given a Hepatitis C diagnostic test at this visit. No treatment is provided as a part of this study, participants who are diagnosed with Hepatitis C infection will be referred to testing locations standard of care for any additional clinical assessments and treatment initiation. A review of the participant's records will be made 12 weeks after their Hepatitis C result and their treatment data are gathered.
Study Type
OBSERVATIONAL
Enrollment
40,000
Participants will be offered finger-stick point-of-care testing for HCV
ACT Justice Health
Canberra, Australian Capital Territory, Australia
NOT_YET_RECRUITINGJustice Health and Forensic Mental Health Network
Sydney, New South Wales, Australia
RECRUITINGQueensland Injectors Health Network Ltd
Bowen Hills, Queensland, Australia
RECRUITINGWest Moreton Hospital and Health Service
Brisbane, Queensland, Australia
RECRUITINGLotus Glen Correctional Centre
Cairns, Queensland, Australia
RECRUITINGTownsville Correctional Centre
Townsville, Queensland, Australia
NOT_YET_RECRUITINGWoodford Correctional Centre
Woodford, Queensland, Australia
RECRUITINGSouth Australian Prison Health Service
Adelaide, South Australia, Australia
NOT_YET_RECRUITINGHepatitis South Australia
Hackney, South Australia, Australia
NOT_YET_RECRUITINGTasmanian Prison Service
Hobart, Tasmania, Australia
NOT_YET_RECRUITING...and 2 more locations
To evaluate the proportion of HCV infected (HCV RNA quantifiable) participants who initiate HCV treatment at 12 weeks following finger-stick point-of-care HCV RNA testing.
HCV treatment
Time frame: 12 weeks from enrolment
To evaluate the proportion of people who accept point-of-care testing among those offered testing.
Accepting testing
Time frame: Recruitment phase
To evaluate the prevalence of current HCV infection (HCV RNA quantifiable) among people tested.
Prevalence
Time frame: Recruitment phase
To evaluate the HCV antibody prevalence among people tested.
Prevalence
Time frame: Recruitment phase
To evaluate the time to treatment uptake among people receiving point-of-care HCV antibody testing with reflex HCV RNA testing in those who are HCV antibody detectable who received HCV treatment;
Time to treatment
Time frame: 52 weeks
To evaluate the proportion of HCV RNA positive participants who initiate HCV treatment at 12 months (52 weeks) following finger-stick point-of-care HCV RNA testing.
Initiation of treatment
Time frame: 52 weeks
To evaluate the proportion of participants who complete HCV direct-acting antiviral (DAA) treatment following point-of-care HCV antibody testing with reflex HCV RNA testing in those who are HCV antibody detectable who received HCV treatment;
Completion of treatment
Time frame: 52 weeks
To evaluate the proportion of participants who achieve an SVR following point-of-care HCV antibody testing with reflex HCV RNA testing in those who are HCV antibody detectable who received HCV treatment
SVR
Time frame: 52 weeks
To evaluate the proportion of participants who are HCV RNA negative at 12 months (52 weeks) following finger-stick point-of-care HCV RNA testing.
HCV negative
Time frame: 52 weeks
To evaluate the cost of point-of-care HCV antibody testing prior to reflex HCV RNA testing compared to direct point-of-care HCV RNA testing and standard of care.
Cost-effectiveness
Time frame: 52 weeks
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